Bayer AG's experimental blood pressure drug worked well in clinical trials and should be approved, but at lower doses, medical reviewers at the U.S. Food and Drug Administration concluded.
The reviewers posted their report on the agency's website in preparation for a meeting on Tuesday of outside medical experts who will discuss the findings and recommend whether the FDA should approve the drug.
The drug is designed to improve exercise capacity in patients with chronic thromboembolic pulmonary hypertension, or CTEPH, who cannot be operated on or who continue to suffer from the condition after surgery.
The drug is also being developed to improve exercise capacity for patients with pulmonary arterial hypertension, or PAH, and to delay worsening of the condition.
The primary safety concerns relate to bleeding, low blood pressure and possible impact on kidney function in some patients. The reviewers said the drug can cause birth defects and a risk-management program would need to be implemented.
© 2021 Thomson/Reuters. All rights reserved.